Method of preparing lyophilized powder for injection comprising aloe and Panax pseudo-ginseng

Abstract

A method of preparing a lyophilized powder for injection, including: (1) weighing and mixing aloe powder and Panax pseudo - ginseng powder to yield an active pharmaceutical ingredient, and mixing the active pharmaceutical ingredient and distilled water to yield a mixed aqueous solution; (2) stiffing the mixed aqueous solution to enable the aloe power and the Panax pseudo - ginseng powder to be completely dissolved, and then allowing the mixed aqueous solution to stand; (3) collecting, filtering, and clarifying a supernate obtained in (2); (4) adding hydrochloric acid to a filtrate obtained in (3) to adjust the pH value of the filtrate, heating and sterilizing the filtrate, and then naturally cooling the filtrate, to yield a cooled liquid; (5) adding hydrochloric acid to the cooled liquid to adjust the pH value of the cooled liquid, filtering the cooled liquid and collecting a pharmaceutical solution; and (6) packaging and lyophilizing the pharmaceutical solution.

The invention claimed is: 
     
       1. A method of preparing a lyophilized powder for injection, the method comprising:
 (1) weighing and mixing between 50 and 99 parts by weight of aloe powder and between 1 and 50 parts by weight of  Panax pseudo - ginseng  powder to yield an active pharmaceutical ingredient, and mixing the active pharmaceutical ingredient and distilled water according to a weight ratio thereof of 100:2000 to yield a mixed aqueous solution; 
 (2) stiffing the mixed aqueous solution to enable the aloe power and the  Panax pseudo - ginseng  powder to be completely dissolved, and then allowing the mixed aqueous solution to stand overnight; 
 (3) collecting, filtering, and clarifying a supernate obtained in (2); 
 (4) adding hydrochloric acid to a filtrate obtained in (3) to adjust a pH value of the filtrate to between 6.3 and 6.5, heating and sterilizing the filtrate at a temperature of between 110 and 120° C. for 30 min, and then naturally cooling the filtrate, to yield a cooled liquid; 
 (5) adding hydrochloric acid to the cooled liquid to adjust a pH value of the cooled liquid to between 4.2 and 4.5, filtering the cooled liquid using an ultrafiltration membrane and collecting a pharmaceutical solution with a molecular weight equal to or less than 10000 Da; and 
 (6) packaging the pharmaceutical solution into ampoules and lyophilizing the pharmaceutical solution. 
 
     
     
       2. The method of  claim 1 , wherein the aloe power is prepared according to following steps:
 (a) soaking fresh aloe leaves for 30-60 min, washing, cleaning, and pulverizing the aloe leaves to yield aloe slurry; 
 (b) adding the aloe slurry to a heating reactor and introducing steam to the heating reactor to heat the aloe slurry to a temperature of between 8 and 12° C., adding a pectase or protease accounting for 0.125 wt. % of the aloe slurry, 50-60 min later, raising the temperature to between 75 and 80° C., and maintaining the temperature for between 3 and 5 hrs for sterilization treatment; and 
 (c) filtering, concentrating, and drying a sterilized aloe solution obtained in (b) to yield a light yellow aloe powder. 
 
     
     
       3. The method of  claim 1 , wherein the  Panax pseudo - ginseng  powder is prepared according to following steps:
 (a) soaking  Panax pseudo - ginseng  for 30-60 min, washing, cleaning, and pulverizing the  Panax pseudo - ginseng  to yield superfine powders having particle sizes of between 0.02 and 15 μm; and 
 (b) adding distilled water to dissolve the superfine powders according to a weight ratio thereof of 100:2000, adding a resulting solution to a heating reactor and introducing steam to the heating reactor to heat the solution to a temperature of between 75 and 80° C., maintaining the temperature for between 3 and 5 hrs, and concentrating and drying the solution to yield a light yellow  Panax pseudo - ginseng  powder. 
 
     
     
       4. The method of  claim 1 , wherein a weight ratio of the aloe power and the  Panax pseudo - ginseng  powder is 50:50. 
     
     
       5. The method of  claim 1 , wherein a weight ratio of the aloe power and the  Panax pseudo - ginseng  powder is 70:30. 
     
     
       6. The method of  claim 1 , wherein a weight ratio of the aloe power and the  Panax pseudo - ginseng  powder is 90:10. 
     
     
       7. The method of  claim 1 , wherein a weight ratio of the aloe power and the  Panax pseudo - ginseng  powder is 99:1.